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Penguin Cold Caps for Breast Cancer
N/A
Waitlist Available
Led By David Page, MD
Research Sponsored by Providence Health & Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post chemotherapy treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if wearing a very cold hat (Penguin cold cap) can help early stage breast cancer patients keep their hair during chemotherapy. The cold hat works by cooling the scalp to protect hair follicles from the treatment. The Penguin cold cap is a type of scalp cooling device used to prevent chemotherapy-induced hair loss, with a history of use in various studies for breast cancer patients.
Eligible Conditions
- Breast Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days post chemotherapy treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post chemotherapy treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Deans Alopecia Scale
Secondary study objectives
Body Image Scale Questionnaire
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Penguin Cold CapsExperimental Treatment1 Intervention
Penguin Cold-cap therapy will commence at least 50 minutes prior to chemotherapy infusion, and will continue for 4 hours following completion of chemotherapy.
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Who is running the clinical trial?
Providence Health & ServicesLead Sponsor
123 Previous Clinical Trials
823,784 Total Patients Enrolled
6 Trials studying Breast Cancer
4,599 Patients Enrolled for Breast Cancer
Medical Specialties of CaliforniaUNKNOWN
David Page, MDPrincipal InvestigatorProvidence Health & Services
5 Previous Clinical Trials
72 Total Patients Enrolled
2 Trials studying Breast Cancer
15 Patients Enrolled for Breast Cancer
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